Clozapine Tablet
NDC Package 48433-024-20

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Clozapine tablets is see also Warning section. This formulation utilizes a tablet delivery system. Marketed by Safecor Health Llc, this product is identified by NDC 48433-024 and is authorized under FDA application ANDA075417.

Identification & Billing

NDC Package Code
48433-024-20
Package Description
100 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (48433-024-01)
Product Code
48433-024
11-Digit Billing Format
48433002420
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Clozapine
Non-Proprietary Name
Clozapine
Substance Name
Clozapine
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLOZAPINE 100 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
See also Warning section. This medication is used to treat certain mental/mood disorders (schizophrenia, schizoaffective disorders). Clozapine is a psychiatric medication (anti-psychotic type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. Clozapine decreases hallucinations and helps prevent suicide in people who are likely to try to harm themselves. It helps you to think more clearly and positively about yourself, feel less nervous, and take part in everyday life.

Regulatory & Marketing

Labeler Name
Safecor Health Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075417
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-23-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 48433-024-20 identifies a specific commercial package of 100 blister pack in 1 carton / 1 tablet in 1 blister pack (48433-024-01) of Clozapine, a human prescription drug labeled by Safecor Health Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains clozapine as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Safecor Health Llc on February 23, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

See also Warning section. This medication is used to treat certain mental/mood disorders (schizophrenia, schizoaffective disorders). Clozapine is a psychiatric medication (anti-psychotic type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. Clozapine decreases hallucinations and helps prevent suicide in people who are likely to try to harm themselves. It helps you to think more clearly and positively about yourself, feel less nervous, and take part in everyday life.

How is this Safecor Health Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48433002420. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
48433-024-20
11-Digit CMS (5-4-2)
48433-0024-20

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.